Methods, apparatus and devices to treat heart valves

ABSTRACT

Apparatus for treating blood flow regurgitation through a native heart valve includes a selective occlusion device sized and configured to be implanted in the native heart valve and selectively operating with at least one of the first or second native leaflets to allow blood flow through the native heart valve when the heart cycle is in diastole and reduce blood flow regurgitation through the native heart valve when the heart cycle is in systole. A clip structure is coupled with the selective occlusion device. The clip structure is configured to be affixed to a margin of at least one of the first or second native leaflets to secure the selective occlusion device to the native heart valve.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.17/144,510, filed Jan. 28, 2021, now U.S. Pat. No. 11,399,940, which isa continuation of U.S. patent application Ser. No. 16/987,927, filedAug. 7, 2020, now U.S. Pat. No. 10,912,646, which is a continuation ofPCT Application Serial No. PCT/US2019/017283 filed Feb. 8, 2019 whichclaims priority to U.S. Provisional Patent Application Ser. No.62/627,894, filed on Feb. 8, 2018, and U.S. Provisional PatentApplication Ser. No. 62/671,077, filed on May 14, 2018, the disclosuresof which are incorporated by reference herein in their entirety.

TECHNICAL FIELD

The present disclosure generally relates to manners of treating heartvalves, and more particularly, manners of reducing regurgitation ofblood flow through the heart valve and thereby improving efficiency andfunctionality of the heart valve.

BACKGROUND

Heart valve incompetence, in various forms and affecting various valvesof the heart (e.g., the aortic valve, tricuspid valve, pulmonary valveand mitral valve), has led to a growing area of research and developmentdesigned to improve heart valve functionality. Although any one or moreof these native heart valves may be compromised due, for example, tocongenital disorders or, more often, disease conditions, the mitralvalve has received particular attention. Regurgitation of blood flowthrough a heart valve, such as a mitral valve, involves the backwardflow of blood through the valve when the valve is supposed to be fullyclosed (i.e., full coaptation of the native leaflets). A diseased orotherwise compromised mitral valve will often allow regurgitated bloodflow from the left ventricle into the left atrium during cardiacsystole. This causes the amount of blood ejected from the left ventricleduring cardiac systole to be reduced, leading to less than optimal“ejection fraction” for the patient. Thus, the patient may experience alower quality of life due to this inefficiency of their heart or, worse,a life-threatening condition.

Surgical techniques as well as transvascular or catheter-basedtechniques for treatment of mitral valve incompetence have beendeveloped and, for example, include mitral annuloplasty, attachment ofthe native anterior mitral leaflet to the native posterior mitralleaflet, chordal replacement and even complete mitral valve replacement.

In many cases, mitral valve regurgitation is related not to congenitaldefects in the mitral valve leaflets but to changes in the coaptation ofthe leaflets over time due to heart disease. In these situations, thenative mitral leaflets are often relatively normal, but theynevertheless fail to prevent regurgitation of blood from the leftventricle into the left atrium during cardiac systole. Instead of thenative anterior and posterior leaflets properly mating or coaptingtogether completely during cardiac contraction or systole, one or moregaps between the native leaflets cause mitral regurgitation.

A current, commonly used technique for reducing mitral valveregurgitation involves the attachment of the native mitral valveanterior leaflet to the native mitral valve posterior leaflet using aclip structure. The clip structure is used to securely affix centrallylocated points on the margins of the anterior and posterior leafletstogether. This causes the mitral valve to essentially be divided intotwo flow control portions, with one on each side of the clip structure.The clip structure may take a simple form that directly clips theanterior leaflet and the posterior leaflet into contact with each otherat the central locations on each leaflet margin, or it may include aspacer against which each leaflet is clipped, such as by a wider, paddletype structure. In either case, the clip structure keeps the mitralleaflets securely together in a manner that withstands the repetitiveforces of the heart cycle.

When the native anterior and posterior mitral leaflets are affixedtogether at approximately the center of the valve (i.e., A2 and P2locations of the native leaflets), there can still be a persistent leakon one or both sides of the clip leading to regurgitation.

It would be useful to further address these and other problems orchallenges associated with heart valve incompetence.

SUMMARY

In a first illustrative embodiment, apparatus for treating blood flowregurgitation through a native heart valve including first and secondnative leaflets is provided and generally includes a selective occlusiondevice and a clip structure. The selective occlusion device is sized andconfigured to be implanted in the native heart valve and selectivelyoperates with at least one of the first or second native leaflets toallow blood flow through the native heart valve when the heart cycle isin the diastole and reduce blood flow regurgitation through the nativeheart found when the heart cycle is in systole. The clip structure iscoupled with the selective occlusion device. The clip structure isconfigured to be affixed to a margin of at least one of the first orsecond native leaflets to secure the selective occlusion device to thenative heart valve.

Various other additional and/or optional features are provided with someexamples summarized below. The clip structure may include a clipcomprised of a pair of clip elements. At least one of the clip elementsis movable between open and closed positions. The clip elements capturenative leaflet tissue therebetween in the closed position. The clipstructure may optionally or additionally comprise first and second clipseach including a pair of clip elements. At least one of the clipelements of each pair is movable between open and closed positionsrelative to the other clip element of each pair. The first clip may beconfigured to attach the first native leaflet to the selective occlusiondevice and the second clip may be configured to attach the second nativeleaflet to the selective occlusion device. As another option, a singleclip structure may be used at approximately a central location betweenopposing native leaflets, such as the anterior and posterior nativeleaflets of the native mitral valve, and this single clip structure maysimultaneously capture leaflet tissue of the anterior and posteriorleaflets. It will be appreciated that the aspects and features discussedherein are applicable to any of the native heart valves, including thepulmonary valve, the tricuspid valve, the aortic valve and the mitralvalve. For an understanding of general principles, illustrativeembodiments are described in connection with treating the native mitralvalve.

As further optional and/or additional features, for example, theselective occlusion device may further comprise a prosthetic heart valveincluding a movable valve element configured to selectively controlblood flow through the native heart valve. The movable valve element mayfurther comprise a flexible membrane configured to engage at least oneof the first or second native leaflets of the native heart valve whenthe heart cycle is in systole and disengage the at least one of thefirst or second native leaflets when the heart cycle is in diastole. Theflexible membrane may further include a closed end and an open end. Theopen end receives blood flow when the heart cycle is in systole toexpand the membrane into engagement with the first and second nativeleaflets in systole, and the open end closes when the heart cycle is indiastole to allow blood flow between the membrane and the first andsecond native leaflets.

As another optional and/or additional feature, some embodiments mayinclude a frame structure coupled with the clip structure. An annulusconnector and, preferably, a non-penetrating annulus connector iscoupled with the frame structure. The annulus connector is configured toengage the heart tissue without penetrating through the tissue. Theframe structure is configured to extend across the native heart valvegenerally between the commissures, in some embodiments, and theselective occlusion device is secured in place generally between theclip structure and the annulus connector. The frame structure may extendacross the native heart valve at locations in addition to or differentfrom the commissure locations. Also in some embodiments, the annulusconnector or connectors provide a first force on heart tissue generallyat the annulus and the clip structure provides an opposing, second force(relative to the first force) at a lower margin of at least one of thefirst or second native leaflets to hold the selective occlusion devicegenerally between the annulus connector(s) and the clip structure.

In some embodiments, the clip structure includes a pair of clip elementsmovable between open and closed positions, and the clip elements capturenative leaflet tissue therebetween in the closed position, and mayeither allow the leaflet tissue to directly engage in an abutting manner(e.g., anterior leaflet to posterior leaflet) or indirectly against aspacer located between leaflet tissue. Particularly, a spacer may bemounted between the pair of clip elements and the native leaflet tissueis engaged between the respective clip elements and the spacer. Also, insome embodiments, the selective occlusion device may further compriseone or more rigid selective occlusion elements sized and configured tobe implanted in the native heart valve such that at least one of thefirst or second native leaflets engages the rigid element when the heartcycle is in systole to reduce regurgitation of blood flow through thenative heart valve, and the at least one of the first or second nativeleaflets disengages the rigid element when the heart cycle is indiastole to allow blood flow through the native heart valve. In someembodiments the selective occlusion device further comprises first andsecond selective occlusion element sized and configured to be implantedin the native heart valve such that at least one of the first or secondnative leaflets engages the first and second selective occlusionelements when the heart cycle is in systole to reduce blood flow throughthe native heart valve, and the at least one of the first or secondnative leaflets disengages the first and second selective occlusionelements when the heart cycle is in diastole to allow blood flow throughthe native heart valve. The selective occlusion element or elements maybe rigid. The term “rigid” is not intended to mean that the selectiveocclusion device has no flexibility, but only that the selectiveocclusion device in these embodiments need not rely on a flexiblemembrane actively moving to engage and/or disengage one or more of thenative leaflets. In other words, the selective occlusion element orelements may be static in operation.

In some embodiments, the apparatus further comprises at least onecatheter carrying the selective occlusion device and/or the clipstructure and/or the frame structure. It will be appreciated that acatheter or transvascular delivery system may include the use ofmultiple catheters. One or more catheters is/are configured to deliverthe selective occlusion device and/or the clip structure and/or theframe structure to the site of the native heart valve. The selectiveocclusion device may have a collapsed condition designed for delivery ina transvascular manner and an expanded condition for implantation in thenative heart valve. Likewise, the frame structure may have a collapsedcondition for delivery through at least one catheter and an expandedcondition for implantation in the native heart valve.

In another illustrative embodiment, apparatus for treating blood flowregurgitation through a native heart valve including first and secondnative leaflets is provided and generally includes a selective occlusiondevice coupled with a frame structure. More particularly, the selectiveocclusion device may be configured in any of the manners contemplatedherein, such as any of the manners summarized above. The frame structureis coupled with at least one non-penetrating annulus connector and theannulus connector is configured to engage with heart tissue withoutpenetrating through the tissue. The frame structure is configured toextend across the native heart valve generally supported by the annulusand the selective occlusion device is secured in place generally betweenthe frame structure and the annulus connector. In some embodiments, forexample, the annulus connector may be an annular element configured toessentially sit on top of the mitral annulus, in the left atrium of thenative heart. In other embodiments, multiple annulus connectors may beutilized. For example, first and second annulus connectors may be usedto sit or locate at the annulus level abutting the respective mitralcommissures or at other generally opposite locations along the nativevalve annulus. It will be appreciated that any of the features discussedand/or contemplated hereby may be combined together to achieveadvantageous results.

In other illustrative aspects, methods for treating blood flowregurgitation through a native heart valve are provided. In someillustrative methods, the method comprises delivering a selectiveocclusion device into the native heart valve between the first andsecond native leaflets. A clip structure is delivered in proximity to amargin of at least one of the first or second native leaflets. The clipstructure is affixed to the margin of the at least one of the first orsecond native leaflets. The selective occlusion device is secured to theclip structure, and the selective occlusion device is then used tooperate with at least one of the first or second native leaflets toallow blood flow through the native heart valve when the heart cycle isin diastole and to reduce blood flow regurgitation through the nativeheart valve when the heart cycle is in systole.

As with other aspects and illustrative embodiments, various additionaland/or optional features of the methods may be employed. The clipstructure may further include a clip comprised of a pair of clipelements and affixing the clip structure may further include moving atleast one of the clip elements between open and closed positions, andcapturing native leaflet tissue between the clip elements in the closedposition. The clip structure, in some embodiments, may further comprisefirst and second clips each including a pair of clip elements, with atleast one of the clip elements of each pair movable between open andclosed positions relative to the other clip element of each pair.Affixing the clip structure may further comprise attaching the firstclip to the first native leaflet and to the selective occlusion device,and attaching the second clip to the second native leaflet and to theselective occlusion device. The selective occlusion device may furthercomprise a prosthetic heart valve including a movable valve element, andusing the selective occlusion device may further comprise selectivelycontrolling blood flow through the native heart valve by moving themovable valve element between open and closed positions. In someembodiments, the movable valve element may further comprise a flexiblemembrane, and using the selective occlusion device may further compriseengaging at least one of the first or second native leaflets of thenative heart valve with the flexible membrane when the heart cycle is insystole to reduce regurgitation of blood flow through the native heartvalve, and disengaging the at least one of the first or second nativeleaflets from the flexible membrane when the heart cycle is in diastoleto allow blood flow through the native heart valve. In some embodimentsthe method comprises engaging the first and second native leaflets ofthe native heart valve with the flexible membrane when the heart is insystole to reduce regurgitation of blood flow through the native heartvalve, and disengaging the first and second native leaflets from theflexible membrane when the heart cycle is in diastole to allow bloodflow through the native heart valve. The flexible membrane may include aclosed end and an open end. Engaging the first and second nativeleaflets may further include receiving blood flow through the open endwhen the heart cycle is in systole to expand the membrane intoengagement with the first and second native leaflets, and disengagingthe first and second native leaflets may include closing the open endwhen the heart cycle is in diastole to allow blood flow between themembrane and the first and second native leaflets.

The method may further comprise coupling a frame structure with the clipstructure. A non-penetrating annulus connector may be engaged with hearttissue proximate the native heart valve annulus, and the frame structuremay be secured across the native heart valve and to the non-penetratingannulus connector such that the selective occlusion device is secured inplace generally between the clip structure and the non-penetratingannulus connector. In some embodiments, a first force may be provided onheart tissue with the annulus connector or connectors, and a secondforce opposing the first force may be provided by the clip structure ata lower margin of at least one of the first or second native leaflets tohold the selective occlusion device between the annulus connector orconnectors and the clip structure. For example, these forces may bepushing and pulling type forces. Also in some embodiments, the methodmay utilize a pair of clip elements as the clip structure, with at leastone of the clip elements movable between open and closed positions, andaffixing the clip structure may further comprise capturing the nativeleaflet tissue between the clip elements and a spacer when the at leastone clip element is moved to the closed position. In other embodiments,the clip structure causes abutting leaflet tissue to directly contactwhen the clip is closed. Also in some embodiments, the selectiveocclusion device may further comprise a rigid element, as generallydiscussed herein, and engaging the rigid element of the selectiveocclusion device with at least one of the first or second nativeleaflets when the heart cycle is in systole reduces blood flowregurgitation through the native heart valve, and disengaging the rigidelement from the at least one of the first or second native leafletswhen the heart cycle is in diastole allows blood flow through the nativeheart valve between the rigid element and the at least one of the firstor second native leaflets.

In various illustrative embodiments of the methods, the selectiveocclusion device and/or the clip structure and/or the frame structure,as well as other components used in the methods, may be delivered andimplanted in a transvascular manner. For example, the selectiveocclusion device may be directed with or without the clip structurethrough at least one catheter with the selective occlusion device in acollapsed condition. The selective occlusion device is extruded from thedistal end of the at least one catheter, and the device is expanded inthe native heart valve. The method may further comprise transvascularlydelivering a frame structure to the native heart valve, transvascularlydelivering the clip structure to the native heart valve, and engaging anon-penetrating annulus connector with heart tissue proximate the nativeheart valve annulus. The frame structure may be secured across thenative heart valve and to the non-penetrating annulus connector suchthat the selective occlusion device is secured in place generallybetween the clip structure and the non-penetrating annulus connector. Inanother optional and/or additional aspect, the method may furthercomprise transvascularly delivering a clip structure capturing device,capturing the clip structure with the capturing device, and connectingthe clip structure to the frame structure during implantation of theselective occlusion device in the native heart valve.

In another illustrative method for treating blood flow regurgitationthrough a native heart valve including at least first and second nativeleaflets, the method comprises delivering a selective occlusion deviceinto the native heart valve between the first and second nativeleaflets. A frame structure is delivered in proximity to the nativeheart valve. The frame structure is affixed to the annulus of the nativeheart valve with a non-penetrating annulus connector. The selectiveocclusion device is secured to the frame structure. The selectiveocclusion device is then used to operate with at least one of the firstor second native leaflets to allow blood flow through the native heartvalve when the heart cycle is in diastole and to reduce blood flowregurgitation through the native heart valve when the heart cycle is insystole. Any of the additional and/or optional features summarized,discussed or otherwise contemplated herein may be used in carrying outthis general method.

In another illustrative embodiment, an apparatus for treating blood flowregurgitation through a native heart valve including first and secondnative leaflets is provided and generally includes a prosthetic heartvalve, and a clip structure. More specifically, the prosthetic heartvalve includes a peripheral, generally cylindrical frame movable betweencollapsed and expanded conditions, and a plurality of prostheticleaflets secured within the peripheral, generally cylindrical frame. Theprosthetic leaflets are movable between open and closed conditions torespectively control blood flow through the prosthetic heart valve. Theframe is implanted by expansion against the first and second nativeleaflets of the native heart valve. The clip structure is coupled withthe frame of the prosthetic heart valve. The clip structure isconfigured to be affixed to a margin of at least one of the first orsecond native leaflets to secure the prosthetic heart valve to thenative heart valve. As optional and/or additional aspects, the clipstructure may further comprise first and second clips each including apair of clip elements, with at least one of the clip elements of eachpair movable between open and closed positions relative to the otherclip element of each pair. The first clip is configured to attach thefirst native leaflet to the prosthetic heart valve and the second clipis configured to attach the second native leaflet to the prostheticheart valve. The prosthetic heart valve may take any desired form, withone example being an expandable stent structure comprising the frame.

As another illustrative method, the prosthetic heart valve may betransvascularly delivered in a collapsed condition to a space within thenative heart valve. The prosthetic heart valve is clipped to the firstand second native leaflets by capturing margins of the first and secondnative leaflets between respective clip elements. The prosthetic heartvalve is expanded against the first and second native leaflets, and theflow of blood is controlled through the native heart valve by movementof the prosthetic leaflets of the prosthetic heart valve. As optionaland/or additional features of the method, clipping the prosthetic heartvalve may further comprise capturing the anterior leaflet of the nativemitral valve with a first clip, and capturing the posterior nativeleaflet of the native mitral valve with a second clip.

In another illustrative embodiment, apparatus for treating blood flowregurgitation through a native heart valve including first and secondnative leaflets generally includes a selective occlusion device and aclip structure capturing device. The selective occlusion device is sizedand configured to be implanted in the native heart valve and selectivelyoperates with at least one of the first or second native leaflets toallow blood flow through the native heart valve when the heart cycle isin diastole and reduce blood flow regurgitation through the native heartvalve when the heart cycle is in systole. The clip structure capturingdevice is extendable from at least one catheter and configured tocapture a clip structure or other anchor securing the first and secondnative leaflets to each other, to allow the clip structure or otheranchor to be coupled with the selective occlusion device. The clipstructure capturing device may further comprise a snare or suture loopdevice. At least one catheter may carry the selective occlusion deviceand the clip structure capturing device. In this case, the at least onecatheter is configured to deliver the selective occlusion device and theclip structure capturing device to the site of the native heart valve,and the selective occlusion device has a collapsed condition fordelivery through the at least one catheter and an expanded condition forimplantation in the native heart valve. It will be appreciated that thedifferent components may be carried and delivered in differentcatheters. Any of the other features or aspects of this disclosure maybe additionally or optionally used in this embodiment.

In another illustrative method, blood flow regurgitation through anative heart valve including first and second native leaflets may betreated by capturing a clip structure or other anchor secured to amargin of at least one of the first or second native leaflets. Aselective occlusion device is delivered into the native heart valvebetween the first and second native leaflets while the clip structure orother anchor is captured, and the selective occlusion device is securedto the clip structure or other anchor. The selective occlusion device isused to operate with at least one of the first or second native leafletsto allow blood flow through the native heart valve when the heart cycleis in diastole and reduce blood flow regurgitation through the nativeheart valve when the heart cycle is in systole. Capturing the clipstructure may further comprise ensnaring the clip structure with atensile member. Securing the selective occlusion device may furthercomprise attaching a tensile member between the clip structure and theselective occlusion device. Securing the selective occlusion device mayfurther comprise attaching the clip structure to a frame member of theselective occlusion device. Again, this method may additionally oroptionally include other features or aspects contemplated by the methodsdisclosed or contemplated herein.

In another illustrative embodiment, a selective occlusion device isprovided for assisting with control of blood flow through a native heartvalve including first and second native leaflets. The selectiveocclusion device is sized and configured to be implanted in the nativeheart valve adjacent a clip structure that separates the native heartvalve into at least two internal valve sections between the first andsecond native leaflets and two external valve sections behind the firstand second native leaflets. Generally, the selective occlusion devicemay be implanted on at least one side of, for example, a clip structurethat secures two native leaflets of a heart valve together and therebyessentially bisects the native valve into two internal sections throughwhich blood will flow through the valve, and two exterior sectionsoutside of the leaflets (i.e., behind the leaflets). The selectiveocclusion device may control blood flow in any desired manner, includingas examples, one or more of the manners contemplated herein.

In another illustrative method, a selective occlusion device isdelivered into the native heart valve between the first and secondnative leaflets and on at least one side of a clip structure separatingthe native heart valve into at least two internal valve sections betweenthe first and second native leaflets and two external valve sectionsbehind the first and second native leaflets. The selective occlusiondevice is used to assist with controlling blood flow through the nativeheart valve during the heart cycle. Again, the selective occlusiondevice may control blood flow in any desired manner, including asexamples, one or more of the manners contemplated herein.

Additional features, aspects and/or advantages will be recognized andappreciated upon further review of a detailed description of theillustrative embodiments taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic view illustrating a system constructed inaccordance with one illustrative embodiment.

FIG. 1B is a schematic perspective view of a native left atrium andmitral valve, similar to FIG. 1A, but illustrating installation of thecatheter delivered selective occlusion device.

FIG. 1C is a schematic perspective view similar to FIG. 1B, butillustrating the membrane of the selective occlusion device in placeover the frame structure.

FIG. 2A is a cross-sectional view taken transversely through theselective occlusion device along line 2A-2A of FIG. 3A when the heartcycle is in systole.

FIG. 2B is a cross-sectional view similar to FIG. 2A, during the systolephase of the heart cycle, but taken along line 2B-2B of FIG. 3A.

FIG. 2C is a cross-sectional view similar to FIG. 2B, but illustratingthe native mitral valve during and the selective occlusion device whilein the diastole phase of the heart cycle.

FIG. 3A is a top view of the native mitral valve and the selectiveocclusion device while the heart is in the systole phase.

FIG. 3B is a top view similar to FIG. 3A, but illustrating the deviceand native mitral valve while the heart is in the diastole phase.

FIG. 4A is a perspective view of the device as shown in the previousfigures, with the membrane of the device removed for clarity, andshowing only the frame structure in solid lines.

FIG. 4B is a perspective view similar to FIG. 4A, but illustrating themembrane applied to the frame structure of the device.

FIG. 5A is a schematic perspective view, partially sectioned similar toFIG. 1A, but illustrating a catheter-based or transcatheter delivery andimplantation system constructed in accordance with another embodiment.

FIG. 5B is a view similar to FIG. 5A, but illustrating a subsequent stepin the method, in which the native mitral leaflets have been capturedand clipped together.

FIG. 5C is a sectional view similar to FIGS. 5A and 5B, but illustratingthe frame of the selective occlusion device implanted and attached tothe clip structure, with the flexible membrane removed for clarity.

FIG. 5D is a view similar to FIG. 5C, but illustrating the flexiblemembrane of the device in place on the frame structure.

FIG. 6A is a perspective view of the frame structure and attached clipstructure shown in FIGS. 5A through 5C.

FIG. 6B is a perspective view similar to FIG. 6A, but illustratinganother embodiment of a collapsible and expandable frame structure.

FIG. 7A is a cross sectional view of the native mitral valve andselective occlusion device of FIG. 6B, with the heart in the diastolephase.

FIG. 7B is a cross sectional view similar to FIG. 7A, but illustratingthe selective occlusion device and the mitral valve when the heart is inthe systole phase.

FIG. 8 is a side view with the heart in cross-section at the location ofthe native mitral valve, illustrating the selective occlusion device,with the membrane in broken lines for clarity, and the device implanted.

FIG. 9 is a perspective view illustrating another embodiment of aselective occlusion device, showing the frame structure in solid linesand the flexible membrane in broken lines for clarity.

FIG. 10A is a schematic perspective view similar to FIGS. 1A and 5A, butillustrating another embodiment of a catheter-based system fordelivering and implanting a selective occlusion device coupled with apre-installed mitral valve leaflet clip structure.

FIG. 10B is a view similar to FIG. 10A, but illustrating a subsequentstep during the method.

FIG. 10C is a perspective view, with the heart sectioned at the nativemitral valve, illustrating the implantation of the selective occlusiondevice, but with the flexible membrane removed for clarity.

FIG. 11A is a perspective view showing another alternative embodiment ofa selective occlusion device with the flexible membrane removed forclarity.

FIG. 11B is a perspective view showing another alternative embodiment ofa selective occlusion device with the flexible membrane removed forclarity.

FIG. 11C is a front top perspective view of the device of FIG. 11A or11B implanted in the native mitral valve.

FIG. 11D is a front view of the device in FIGS. 11A through 11C.

FIG. 11E is a transverse cross section of FIG. 11D.

FIG. 12A is a perspective view of another alternative embodiment of aselective occlusion device implanted in the native mitral valve, whichis shown in cross-section similar to previous figures.

FIG. 12B is a cross-sectional view of the heart, taken at the nativemitral valve, and showing the selective occlusion device of FIG. 12A inside elevation.

FIG. 12C is a view similar to FIG. 12B, but illustrating anotheralternative embodiment of a selective occlusion device implanted in anative mitral valve.

FIG. 12D is another view similar to FIG. 12C, but illustrating anotheralternative embodiment of a selective occlusion device implanted in thenative mitral valve.

FIG. 13A is a transverse cross-sectional view taken through the mitralvalve and generally through one of the selective occlusion elements ofFIGS. 12A through 12D, to show sealing during systole.

FIG. 13B is a view similar to FIG. 13A, but showing the selectiveocclusion element and the mitral valve when the heart is in the diastolephase.

FIG. 13C is a view similar to FIG. 13B, but showing another embodimentof the selective occlusion element.

FIG. 14A is a perspective view of another alternative embodiment of aselective occlusion device and mitral valve clip structure.

FIG. 14B is a perspective view of another alternative embodiment of aselective occlusion device and mitral valve clip structure.

FIG. 14C is a perspective view of another alternative embodiment of aselective occlusion device and mitral valve clip structure.

FIG. 15A is a perspective view of another alternative embodiment of aselective occlusion device with the flexible membrane of the devicebroken away for clarity.

FIG. 15B is a perspective view similar to FIG. 15A, but furtherillustrating a flexible membrane on the frame structure.

FIG. 15C is a side elevational view of the selective occlusion deviceshown in FIGS. 15A and 15B with the flexible membrane removed forclarity.

FIG. 15D is a side elevation view similar to FIG. 15C, but illustratingthe flexible membrane applied to the frame structure.

FIG. 15E is a top view of the device shown in FIGS. 15A through 15D, butillustrating the membrane cross-sectioned to show the membrane shape inthe expanded or filled condition when the heart is in the systole phase.

FIG. 16A is a perspective view of a system and of the heart, similar toFIG. 5A, but illustrating another alternative embodiment of acatheter-based system and method for implanting a selective occlusiondevice and a clip structure in the native mitral valve.

FIG. 16B is a perspective view similar to FIG. 16A, but illustrating asubsequent step in the method.

FIG. 16C is a view similar to FIG. 16B, but illustrating anothersubsequent step in the method.

FIG. 16D is a perspective view illustrating the implanted selectiveocclusion device in the mitral valve of the patient.

FIG. 17A is a side cross-sectional view of the native mitral valve andof the selective occlusion device of FIGS. 16A through 16D beingimplanted and secured to the mitral valve clip structure.

FIG. 17B is a side cross-sectional view similar to FIG. 17A, butillustrating a subsequent step in the method.

FIG. 17C is a side cross-sectional view similar to FIG. 17B, butillustrating another subsequent step in the method in which theapparatus is fully implanted.

FIG. 18A is a cross sectional view of the selective occlusion device, asshown in FIGS. 16A through 16D and 17A through 17C, with the device andmitral valve shown when the heart is in the diastole phase.

FIG. 18B is a view similar to FIG. 18A, but illustrating the device andthe native mitral valve when the heart is in the systole phase.

FIG. 19 is a top view schematically illustrating a representation forthe shape of the selective occlusion device when implanted in a nativemitral valve having an anatomical curvature.

FIG. 20 is a perspective view of a selective occlusion deviceconstructed in accordance with another alternative embodiment.

FIG. 21A is a side cross-sectional view taken generally lengthwise alonga central portion of the device shown in FIG. 20 .

FIG. 21B is a top view of the device shown in FIG. 21A.

FIG. 21C is a cross-sectional view of the device shown in FIG. 21B.

FIG. 22A is a perspective view of a catheter-based system and methodaccording to another alternative embodiment being performed on a nativemitral valve, shown in a schematic cross-sectioned portion of the heart.

FIG. 22B is a view similar to FIG. 22A, but illustrating a subsequentstep in the method.

FIG. 22C is a view similar to FIG. 22B, but illustrating anothersubsequent step in the method.

FIG. 22D is a perspective view illustrating the fully implantedapparatus in the native mitral valve, resulting from the method shown inFIGS. 22A through 22C.

FIG. 22E is a view similar to FIG. 22D, but illustrating an alternativeframe structure attached to the selective occlusion device.

FIG. 22F is a view similar to FIG. 22E, but illustrating anotheralternative frame structure.

FIG. 22G is a view similar to FIG. 22F, but illustrating anotheralternative frame structure.

FIG. 23A is a cross-sectional view of a native mitral valve and anotherembodiment of a heart valve repair apparatus, shown with the heart inthe systole phase.

FIG. 23B is a view similar to FIG. 23A, but illustrating the apparatusand the mitral valve when the heart is in the diastole phase.

FIG. 24 is a side cross-sectional view of another alternative embodimentof a heart valve repair apparatus implanted in a native mitral valve.

FIG. 25A is a cross-sectional view of another alternative embodiment ofa heart valve repair apparatus.

FIG. 25B is a cross-sectional view of another alternative embodiment ofa heart valve repair apparatus implanted in a native mitral valve.

FIG. 26A is another alternative embodiment of a selective occlusiondevice shown in cross-section.

FIG. 26B is a schematic view illustrating the device of FIG. 26Aimplanted in a native mitral valve.

FIG. 26C is a perspective view illustrating the device of FIGS. 26A and26B implanted in a native mitral valve.

FIG. 26D is a cross-sectional view of another alternative heart valverepair apparatus implanted in a native mitral valve.

FIG. 26E is a cross-sectional view of another alternative heart valverepair apparatus implanted in a native mitral valve.

FIG. 27A is a perspective view of another alternative selectiveocclusion device.

FIG. 27B is a lengthwise cross-sectional view of the device shown inFIG. 27A, schematically illustrating blood flow during the systole phaseof the heart.

FIG. 27C is a transverse cross-sectional view illustrating the device ofFIGS. 27A and 27B during systole.

FIG. 28A is a perspective view illustrating another alternativeembodiment of another apparatus including a selective occlusion devicetogether with a mitral valve clip structure.

FIG. 28B is a lengthwise cross-sectional view illustrating the deviceand clip structure shown in FIG. 28A.

FIG. 28C is a transverse cross-sectional view illustrating the device ofFIGS. 28A and 28B.

FIG. 29A is a cross-sectional view of a selective occlusion device andclip structure schematically illustrating blood flow between theinterior membrane wall surfaces during the heart systole phase.

FIG. 29B is a cross sectional view of the apparatus of FIG. 29Aimplanted in the native mitral valve and illustrating the device and themitral valve when the heart is in the systole phase.

FIG. 30 is a perspective view illustrating the mitral valve incross-section and the fully implanted selective occlusion device andclip structure.

FIG. 31 is a perspective view of another alternative embodimentillustrating a prosthetic heart valve and leaflet clip structures.

FIG. 32A is a side elevational view, partially fragmented to show theprosthetic heart valve and leaflet clip structures.

FIG. 32B is a side elevational view with the native heart valve incross-section, illustrating an initial portion of the implantationprocedure associated with the prosthetic heart valve of FIGS. 31 and32A.

FIG. 32C is a view similar to FIG. 32B, but illustrating a subsequentstep in the method.

FIG. 32D is a view similar to FIG. 32C, but illustrating a subsequentstep in the method.

FIG. 32E is a view similar to FIG. 32D, but illustrating the fullyimplanted prosthetic heart valve clipped to the native heart valveleaflets and expanded into an implanted condition.

FIG. 33 is a perspective view of another alternative embodiment of aprosthetic heart valve and native leaflet clip structure.

FIG. 34A is a side elevational view of the prosthetic heart valveillustrated in FIG. 33 .

FIG. 34B is a view of the prosthetic heart valve of FIG. 34A implantedin a native heart valve.

FIG. 35A is a cross sectional view similar to FIG. 29B, but illustratinganother illustrative embodiment of a heart valve repair apparatusimplanted in a mitral valve and showing the systole phase of the heartcycle.

FIG. 35B is a cross sectional view similar to FIG. 35A, but illustratingthe apparatus and mitral valve when the heart cycle is in the diastolephase.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The detailed description herein serves to describe non-limitingembodiments or examples involving various inventive concepts and usesreference numbers for ease of understanding these examples. Commonreference numbers between the figures refer to common features andstructure having the same or similar functions, as will be understood.While various figures will have common reference numbers referring tosuch common features and structure, for purposes of conciseness, laterfigure descriptions will not necessarily repeat a discussion of thesefeatures and structure.

Referring first to FIG. 1A, a native heart 10 is shown and includes aleft atrium 12, a left ventricle 14, and a native mitral valve 16, whichcontrols blood flow from the left atrium 12 to the left ventricle 14.The tricuspid valve 18 is also shown in communication with the rightventricle 19. The mitral valve 16 includes an anterior leaflet 16 a, aposterior leaflet 16 b and a native valve annulus 16 c. When the mitralvalve 16 is functioning properly, it will open to allow blood flow fromthe left atrium 12 into the left ventricle 14 during the diastoleportion of the heart cycle. When the heart 10 contracts during systole,the anterior and posterior native mitral leaflets 16 a, 16 b will fullycoapt or engage with one another to stop any blood flow in the reversedirection into the left atrium 12 and blood in the left ventricle 14will be ejected efficiently and fully through the aortic valve (notshown). A catheter 20 carries a collapsed selective occlusion device 22along a guide wire 24. In this illustrative procedure, the catheter 20is delivered transeptally across the inter-atrial septum 12 a. It willbe appreciated that any other transcatheter approach, or other surgicalapproaches of various levels of invasiveness, may be used instead. Thepatient may or may not be on bypass and the heart may or may not bebeating during the procedure. As further shown in FIG. 1A, the nativemitral leaflets 16 a, 16 b are supported by chordae tendineae 26attached to papillary muscles 28. As schematically illustrated in FIG.1A, the anterior and posterior native mitral leaflets 16 a, 16 b may notproperly coapt or engage with one another when the heart cycle is insystole. Insufficient coaptation of the leaflets 16 a, 16 b leads toblood flow out of the left ventricle 14 in a backward direction, or inregurgitation, through the mitral valve 16 into the left atrium 12instead of fully through the aortic valve (not shown).

Now referring to FIG. 1A in conjunction with FIGS. 1B and 10 , theselective occlusion device 22 has been fully extruded or extended fromthe distal end 20 a of the catheter 20, and transformed from thecollapsed position or condition shown in FIG. 1A within the catheter 20,to the expanded condition shown in FIGS. 1B and 10 . As further shown inFIGS. 1B and 10 , the selective occlusion device 22 comprises acollapsible and expandable frame structure 30. The frame structure 30 iscomprised of a curved frame member 32 generally extending across thenative mitral valve 16 while being supported or stabilized at the nativeannulus 16 c. The selective occlusion device 22 is formed in a mannerallowing it to be collapsed for delivery as shown in FIG. 1A, butexpanded to the exemplary form shown in FIGS. 1B and 10 . This may beaccomplished in many ways. For example, the frame structure 30 may becomprised of flexible polymers, metals such as super-elastic or shapememory metals or other materials. The selective occlusion device 22 may,for example, expand into a preformed shape through the use of shapememory materials. The frame structure 30 may be covered partially orcompletely by fabrics such as the Dacron, Teflon and/or other coveringmaterials such as used in the manufacture of prosthetic cardiac valvesor other implants. More specifically, the frame structure 30 includes acurved frame member 32 which, in this embodiment, and/or otherembodiments, extends from one commissure to the other. The frame member32 may instead extend from other portions of the heart tissue generallylocated at the annulus region. At opposite ends, the frame structure 30is supported by respective first and second non-penetrating annulusconnectors 34, 36. As an example of a non-penetrating annulus connector,these connectors are configured with respective upper and lowerconnector elements 34 a, 34 b and 36 a, 36 b. These connector elements34 a, 34 b and 36 a, 36 b respectively sandwich or capture annulustissue therebetween at each commissure. The connector elements 34 a, 34b and 36 a, 36 b are each shown as “butterfly-type” connectors that maybe slipped or inserted into place with native leaflet tissue sandwichedor secured therebetween. It will be appreciated that other tissuetrapping connectors may be used instead, and/or other penetrating ornon-penetrating connectors. Non-penetrating connectors are advantageousbecause they cause no damage that would otherwise occur due topenetrating connectors, and they allow for position adjustment. Theframe structure 30 further includes first and second membrane supportmembers 38, 40 at opposite ends configured to be located in the leftventricle 14 to support a flexible membrane 44 in a slightly opencondition. Together with the frame structure 30, the flexible membrane44 forms a selective occlusion device that works in conjunction with thenative mitral valve leaflets 16 a, 16 b to control blood flow throughthe mitral valve 16. The flexible membrane 44, in this embodiment actsas a prosthetic heart valve by moving in coordination with the leaflets16 a, 16 b as will be described below. In other embodiments, theselective occlusion device need not have any moving part that moves inconjunction with the leaflets 16 a, 16 b. The flexible membrane 44 issecured at opposite portions of the frame structure 30 to the supportmembers 38, 40 in any suitable manner, such as adhesive, mechanicalsecurement, suturing, fasteners, etc. As further shown, a considerableportion at a lower margin of the flexible membrane 44 is not attached tothe frame structure 30. The membrane support members 38, 40 are short,curved members and remaining membrane portions at the lower margin ofthe flexible membrane 44 are not directly attached to any frame portion.This allows the flexible membrane to billow, expand or inflate outwardas will be discussed further below during systole to engage with thenative leaflets 16 a, 16 b and prevent regurgitation of blood flow in areverse direction through the mitral valve 16 when the heart cycle is insystole.

The flexible membrane 44 may be formed of various types of thin,flexible materials. For example, the materials may be natural, syntheticor bioengineered materials. Materials may include valve tissue orpericardial tissue from animals, such as cows and pigs, or othersources. Synthetic materials such as ePTFE, Dacron, Teflon or othermaterials or combinations of materials may be used to construct theflexible membrane 44. Flexibility of the frame structure 30 togetherwith the flexibility of the flexible membrane 44 provides for operationof the selective occlusion device 22 and the manners contemplatedherein, and may also help prevent failure due to fatigue from repeatedcycling movement of the selective occlusion device 22 in the heart 10.It will be appreciated that FIG. 1B shows the flexible membrane 44removed for a clear view of the frame structure 30, and in this figurethe flexible membrane 44 is in broken lines, while in FIG. 10 theflexible membrane 44 is shown in solid lines, with the heart cycle insystole and the flexible membrane 44 fully engaging the native leaflets16 a, 16 b to reduce regurgitation of blood flow through the mitralvalve 16. The flexible membrane 44 may be sutured to the frame structure30 using techniques employed by the prosthetic heart valve industry forthe manufacture of prosthetic aortic and mitral valves. The frame may bemade from one or more layers of material, such as super-elastic or shapememory material and the membrane 44 may be suitably secured. One mannermay be trapping the flexible membrane 44 between layers of the framestructure 30. To retain the membrane 44 in place, fabric covering(s)(not shown) over a metallic frame may aid in attaching the membrane 44to the frame structure 30.

FIGS. 2A, 2B and 2C are transverse cross-sections through the selectiveocclusion device 22 and the mitral valve 16 shown in FIGS. 1A through 10. FIG. 2A illustrates the device 22 in a cross section along line 2A-2Aof FIG. 3A, while FIG. 2B shows the selective occlusion device 22 incross section along line 2B-2B of FIG. 3A, with each of these twofigures showing the heart cycle in systole. FIGS. 3A and 3B are topviews respectively showing the systole and diastole conditions, but notillustrating the hinge 32 a that may be provided to assist with foldingduring delivery. FIG. 2C is similar to FIG. 2B but showing the selectiveocclusion device 22 when the heart cycle is in diastole. In systole(FIGS. 2A, 2B and 3A), which is when the native mitral valve 16 issupposed to fully close to prevent blood flow back into the left atrium12, the pressurized blood will flow through the open end 45 of theflexible membrane and be prevented from flowing through the closed end47, at least to any substantial degree. As will be appreciated from areview of some embodiments, a small vent may be provided in the flexiblemembrane. Because the flexible membrane billows or expands outwardly inthe direction of the arrows shown in FIG. 2B, the native mitral leaflets16 a, 16 b will seal against or coapt with the flexible membrane 44 toprevent blood flow regurgitation. In this manner, native mitral leaflets16 a, 16 b that would not otherwise properly seal together or coapt willseal in systole against the flexible membrane 44. To ensure coaptation,one or more portions of the flexible membrane 44 adjacent to framestructure 30 will move away from the adjacent frame structure intocontact with the native leaflet(s) 16 a, 16 b. In other words, only aportion of the lower margin of the flexible membrane 44 is affixed toframe structure 30. As further shown in FIG. 2B, there may be extramembrane material adjacent the membrane support members 38, 40 to allowfor the expanded membrane condition. As further shown in FIGS. 2C and3B, when the heart cycle is in diastole and blood flow needs to occurfrom the left atrium 12 into the left ventricle 14 (during the fillingportion of the heart cycle), the blood will push past the flexiblemembrane 44 and the flexible membrane 44 will move into a collapsed orcontracted condition while the native mitral leaflets 16 a, 16 b moveapart or away from each other in the opposite direction to facilitateblood flow in the direction of the arrows. The arch-shaped membranesupport members 38, 40 maintain a separation between lower margins oredges of the flexible membrane 44 to force blood to fill the inside orinterior of the membrane 44 during systole through the open end 45,causing the membrane 44 to expand or billow outward so that the membrane44 fills the gap between the native mitral valve leaflets 16 a, 16 b.The arch-shaped or curved support members 38, 40, and/or other portionsof the frame structure 30, may be formed using a central wire and afabric cover around the wire. Other constructions are possible as well,such as using soft, sponge-like material, and fabrics in conjunctionwith more structurally supportive material such as metal and/or plastic.The filling and emptying of the flexible membrane 44 through the openend 45 can ensure that there is washing or rinsing of the underside ofthe membrane 44 with each heartbeat to prevent clot formation, and anyresulting embolization of clot material.

FIGS. 4A and 4B are respectively similar to FIGS. 1B and 10 , butillustrate the selective occlusion device 22 isolated from the nativemitral valve 16 (FIGS. 1B and 1C).

FIGS. 5A through 5D illustrate another embodiment of a selectiveocclusion device 22 a. As previously stated, all like reference numeralsbetween the various embodiments and figures refer to like structure andfunction except to the extent described herein. Some reference numeralswill have a suffix modification such as a letter (e.g., “22 a”), or aprime mark (e.g., 90′), indicating a modification to the like structurewhich will be discussed and/or apparent from a review of the drawings.To be more concise, redundant descriptions of like structure andfunction between the various figures will not be made or will be kept toa minimum. This embodiment is particularly suited to achieve beneficialeffects for those mitral valve repairs involving clipping or otherwisesecuring one native leaflet margin to another. It will be appreciated,though, that clips or other anchors (herein generically referred to asclip structures) may be applied to only one leaflet margin, and morethan one clip or anchor may be used. Often, mitral valve repair is madewith a clip structure 50 having first and second clip elements 50 a, 50b movable toward each other from an open condition to a closed position.The clip structure 50 is typically applied in a transcatheter procedureusing a suitable catheter assembly 52. A representative and illustrativeclip structure 50 is shown in these figures for clipping togethermargins of the native leaflets 16 a, 16 b near a central location ofeach margin. The beginning of the procedure is shown in FIG. 5A with thecatheter assembly 52 directed transeptally into the left atrium 12through the inter-atrial septum 12 a and into the mitral valve 16 and tothe left ventricle 14. A portion of the margin of each leaflet 16 a, 16b is captured by the clip structure 50 and then clipped and firmlysecured together as shown in FIG. 5B. At least one of the elements 50 a,50 b moves toward the other in a clipping or clamping action to changefrom an open condition to a closed condition. A wire, suture or othertensile member or connector 54 is coupled to the clip structure 50. Ator near the end of the clipping step of the method, a selectiveocclusion device 22 a in the form of a frame structure 30 a and flexiblemembrane 44 a (FIG. 5D) is introduced through the catheter or catheters52 in a manner similar to the method described above with respect to thefirst embodiment. The selective occlusion device 22 a is guided by thesuture, wire or other tensile member 54 affixed and extending from theclip structure 50.

As further shown in FIG. 5C, this embodiment of the device 30 a, 44 aincludes two sections 60, 62. This embodiment advantageously utilizesthe clip structure 50 as an anchoring mechanism for assisting withsecuring the device 30 a, 44 a in place and implanted as a selectiveocclusion device 22 a in the native mitral valve 16. The two sections60, 62 are employed in a manner described above in connection with thesingle section embodiment of the device 30, 44. As will be appreciatedfrom a review of FIGS. 5C and 5D, a modified frame structure 30 a isemployed to support a modified flexible membrane 44 a. Morespecifically, the flexible membrane 44 a includes corresponding sections44 a 1 and 44 a 2. These may be formed from one or more distinct piecesof membrane material. In addition, third and fourth membrane supportmembers 64, 66 are provided to support the flexible membrane sections 44a 1 and 44 a 2 in manners similar and analogous to the manner thatsupport members 38, 40 support and function in the first illustrativeembodiment discussed above. An arc-shaped frame member 32 is shownsimilar to the first embodiment spanning across the native valve 16.Vertical support members 65, 67 extend from the frame member 32 andcouple with the membrane support members 64, 66. As another option, theframe member 32 may be eliminated and the vertical members 65, 67 orother structure could be joined together in the central region of thedevice 22 a.

As further shown best in FIG. 5C, the suture or wire 54 couples the clipstructure 50 to the frame structure 30 a, such as by using a crimpelement or other securement 68 generally at hinge 32 a. It will beappreciated that other securement methods and structures may be usedinstead to secure the clip structure 50 to the frame structure 30 a. Theclip structure 50 and the frame structure 30 a may take other forms thanthe illustrative forms shown and described herein. Use of the clipstructure 50 securing the frame structure 30 a in addition to thenon-penetrating and/or other connectors such as generally at the nativeannulus 16 c provides for an overall secure implant. The clip structure50 and one or more annulus connectors will provide opposing forces thatfirmly secure the frame structure 30 a and flexible membrane 44 agenerally therebetween. The two separate selective occlusion or flowcontrol sections 44 a 1, 44 a 2 are separated from each other by theclip structure 50. The attachment of the selective occlusion device 22 ato the native mitral valve 16 may be a direct connection between theflexible membrane 44 a and the native leaflets 16 a, 16 b (see below).Another option is that instead of the single arch-type frame member 32,the two side-by-side sections 60, 62 of the frame structure 30 a may beotherwise coupled together near the center of the selective occlusiondevice 22 a to avoid the need for a continuous frame member 32 spanningacross the native mitral valve 16. Still further modifications arepossible, while retaining advantages of a clip structure used incombination with a selective occlusion device. For example, theselective occlusion device may be configured as a frame structure andflexible membrane affixed around a continuous perimeter portion of theframe structure.

FIGS. 6A and 6B illustrate additional embodiments of selective occlusiondevices 22 b and 22 c. In these figures the flexible membrane 44 a isshown in broken lines so that the respective frame structures 30 b, 30 care more clearly shown. In the illustrative embodiment of FIG. 6A, thecentral hinge has been eliminated and the suture or wire 54 extendsdirectly through the frame member 32. As with all embodiments, thedevices 22 b, 22 c and any associated components, such as the framestructures 30 b, 30 c, may be made flexible enough and foldable into acollapsed condition for catheter delivery purposes. Again, a crimpelement (not shown) or any other fixation manner may be used to securethe wire or suture 54 in tension against the frame structure 30 b, 30 c.FIG. 6B illustrates an embodiment of the selective occlusion device 22 cslightly different from the embodiment of FIG. 6A in that the flexiblemembrane 44 a, shown in broken lines, is folded inwardly at the regionof the clip structure 50. As shown in FIG. 6A, and as one additionaloption, the flexible membrane 44 a may be more distinctly attached tothe frame members as shown by the broken lines extending upwardlyagainst the vertical frame members 65, 67.

FIGS. 7A and 7B are top views illustrating selective occlusion device 22c, such as shown in FIG. 6B having separate sections 44 a 1 and 44 a 2secured in place and implanted within a native mitral valve 16. FIG. 7Ashows the selective occlusion device 22 c when the heart cycle is indiastole, and FIG. 7B shows the selective occlusion device 22 c when theheart cycle is in systole. The function of a multi-section apparatus,such as with devices 22 a, 22 b, 22 c, is similar to the function of thesingle section selective occlusion device 22 discussed above inconnection with the first illustrative embodiment, except that with thenative mitral valve itself separated into two sections by the clipstructure 50, the separate flexible membrane sections 44 a 1 and 44 a 2independently function to contract or collapse in diastole (FIG. 7A) andbillow, expand or inflate outwardly in systole (FIG. 7B) due to theforceful introduction of blood flow when the heart cycle is in systole.The effect or result is similar to that described above in connectionwith, for example, FIGS. 3A and 3B, but with the dual effect ofcorrecting any misalignment or lack of coaptation between the nativemitral leaflets 16 a, 16 b on each side of the clip structure 50. Inthis manner, blood flow is allowed in diastole as shown in FIG. 7A pastthe native mitral leaflets 16 a, 16 b which have spread or expandedoutwardly and also past the two section flexible membrane 44 a which hascollapsed inwardly or away from the native mitral leaflets 16 a, 16 b.Reverse or regurgitated blood flow is at least reduced, if not reducedto essentially zero (prevented), during systole as the flexible membrane44 a expands or inflates to contact or engage the native mitral leaflets16 a, 16 b creating a fluid seal.

FIG. 8 shows a side view of the selective occlusion device 22 c shown inFIG. 7B, but with the flexible membrane 44 a shown in broken lines forclarity. The selective occlusion device 22 c is securely implanted inthe mitral valve 16 between annulus connectors 34, 36 generally at anupper location and a clip structure 50 at a lower location. Again,different connector and/or clip configurations may be used than thoseshown and described, and different numbers of connectors and clipstructures may be used. The clip structure or structures may be securedto each leaflet 16 a, 16 b simultaneously as shown, or may be securedseparately to a single leaflet 16 a and/or 16 b. Although the tensilemember 54 is shown to have a particular length to connect between theclip structure 50 and the frame member 32, a tensile member or othertype of connection of any necessary longer or shorter extent may be usedinstead. In some cases, the clip structure 50 may be directly affixed tothe frame structure 30.

FIG. 9 illustrates a selective occlusion device 22 d constructedaccording to an illustrative embodiment, in which an alternativelyconfigured frame structure 30 d is used and coupled with a flexiblemembrane 44 (shown in broken lines for clarity. Particularly, lowersupporting members 70, 72, 74, 76 have a different configuration forguiding the shape of the flexible membrane 44. The flexible membrane 44may be securely attached to the lower supporting members 70, 72, 74, 76along their entire lengths, or along a portion of their lengths, or notat all if they are otherwise held in place during diastole in a suitablemanner. The lower margins of the flexible membrane 44 are allowed tobillow or expand outwardly and may be detached from the lower supportingmembers 70, 72, 74, 76 along at least substantial portions to allow thisexpanding or billowing action to take place. In addition, the entireframe structure 30 d and/or only the lower supporting members 70, 72,74, 76 may be highly flexible to allow this expansion or billowingaction to take place when the heart cycle is in systole, as previouslydescribed.

FIGS. 10A, 10B and 10C show another illustrative embodiment in which atranscatheter system 52 is used and, specifically, a clip structurecapturing device 80 is used to help secure the selective occlusiondevice 22 a in place. This may be particularly useful when applying aselective occlusion device such as according to the present disclosureto a previously implanted mitral clip structure 50. The clip structure50 may be of any type or configuration. In cases where the clipstructure 50 has failed to properly repair the mitral valve 16, or themitral valve function has degraded over time, despite the clip repairprocedure, this embodiment assists with the capturing of the previouslyimplanted clip structure 50 and implantation of a selective occlusiondevice, such as frame structure 30 a and flexible membrane 44 a. In thisregard, and as shown in FIGS. 10A and 10B, a lasso or suture loop device81 is deployed from a catheter 82 and captures the clip structure 50with assistance from a guide device 83. The suture, wire or othertensile member 54 that extends upwardly through the mitral valve 16 maybe a part of the suture loop device 81 in this embodiment and may thenbe used as generally described above to guide and securely affixselective occlusion device 22 a, to the clip structure 50, as shown inFIG. 10C. For clarity, the flexible membrane 44 a has not been shown inFIG. 10C.

FIGS. 11A and 11B illustrate two additional embodiments of selectiveocclusion devices 22 e, 22 f, without showing the flexible membranes,that may be used to prevent blood flow regurgitation through a heartvalve such as, by way of example, the mitral valve 16. In theseembodiments, a flexible membrane 44 a (FIGS. 110 through 11E) may besecured over a frame structure 90, 90′ from one end to the other, suchas between two non-penetrating annulus connectors or, in otherembodiments, penetrating connector portions 92, 94, 92′, 94′.Advantageously, there are two spaced apart elongate frame members 96, 98extending between the connectors 92, 94, 92′, 94′, each having an upwardbend or hump 100, 102 creating a recessed space. As shown in FIG. 110the flexible membrane 44 a is carried on this frame structure 90, 90′and may be secured to the frame members 96, 98 along all or some of thelengths thereof. This can leave a desired portion of the flexiblemembrane 44 a at the lower margin of the frame structures 90, 90′unsecured and able to expand or billow in outward direction duringsystole, generally as described above in prior described embodiments orin later described embodiments. This outward expansion or billowingaction will allow the flexible membrane 44 a to better contact or engagethe natural leaflet tissue during systole to prevent regurgitation ofblood flow. This will also allow for more exchange of blood beneath orwithin the flexible membrane to prevent blood stagnation and theresulting possibility of clotting which may embolize and cause stroke orother complications. The humps 100, 102 in each of the lower, spacedapart support members 96, 98 accommodate the clip structure 50 andgenerally receive that portion of the mitral valve 16 fastened togetherat the A2/P2 junction. A central connection element, such as a hole 104,is provided in a central frame member 105 and allows a wire, suture orother tensile member 54 to attach the frame structure 90, 90′ to theclip structure 50. The central frame member connects the annulusconnectors 92, 94 and 92′, 94′ together and arches over and across themitral valve 16 in a manner similar to frame member 32. Suitableconfigurations of the frame structure 90, 90′ may be used, such as anyof those previously described, for accommodating one or more clipstructures and forming a plurality of separate flexible membranesections, for example, with one section on each side of a clip structure50. FIGS. 11A and 11B also show another way of attaching a framestructure generally at the native annulus 16 c with one or more holes106, 108, 110, 112 to engage with a suitable fixation element or anchor114 (FIG. 11D). The embodiment of FIG. 11D includes two additionalfixation holes 116, 118 for receiving fasteners. In some embodimentssuch as shown in FIG. 11D, penetrating anchors may be used, such asrivets, T-bars, pledgets, or other fixation elements, although thebenefits of non-penetrating connectors in accordance with thisdisclosure would be desirable, such as for purposes of allowingself-adjustment and reduced tissue damage.

FIGS. 12A and 12B illustrate another illustrative embodiment of aselective occlusion device 22 g. Rather than employing a flexiblemembrane, this apparatus includes at least one rigid occlusion element120. This embodiment is more specifically configured to operate inconjunction with mitral valve leaflets 16 a, 16 b that have been affixedtogether at a central location along their margins with a clip structure50 such as a clip structure previously described. Therefore, twoselective occlusion elements 120 are provided for reasons analogous tothe two section flexible membrane embodiments described herein. Theselective occlusion elements 120 are “rigid” in use within the mitralvalve 16 in that they are static and need not flex inwardly or outwardlyto engage and disengage the native mitral leaflets 16 a, 16 b during thesystole and diastole portions of the heart cycle. Instead, thesedisk-shaped elements 120 retain their shape and are sized and located inthe native mitral valve 16 such that the native mitral leaflets 16 a, 16b engage the elements 120 during systole and disengage the elements 120during diastole. This selective or cyclical interaction is shown inFIGS. 13A and 13B, to be described further below. The device 22 g shownin FIGS. 12A and 12B includes a frame structure 30 e that is configuredto extend generally across the native mitral valve 16, with a framemember 32 and hinge 32 a as generally described in previous embodiments,along with non-penetrating annulus connectors 34, 36 as also previouslydescribed. Further, the clip structure 50 is secured to the framestructure 30 e with a crimp element 68 and a suture, wire or othertensile member 54, such as in one of the previously described manners.In this way, the first and second rigid, selective occlusion elements120 are respectively disposed on opposite sides of the native mitralvalve 16 and on opposite sides of the clip structure 50 to selectivelyinclude the openings in the native mitral valve 16 formed when the clipstructure 50 is affixed to each leaflet 16 a, 16 b bringing centralportions of the two leaflet margins together either in direct contactwith each other or in contact with a spacer (not shown) disposed betweenthe movable clip elements. In this embodiment, the frame structure 30 eis formed with a curved or arch-type frame member 32 configured toextend over the native mitral valve 16 in the left atrium 12.

The selective occlusion device 22 g is shown when the heart cycle is insystole in FIGS. 12A, 12B and 13A. The native anterior and posteriormitral valve leaflets 16 a, 16 b are shown being forced inwardly towardeach other. There is no blood leak or regurgitation because the staticocclusion elements 120 fill any residual gap between the anterior andposterior leaflets 16 a, 16 b. The elements 120 do not need to be of thedepicted shape. Any shape of space filling would be sufficient if thegap between the two leaflets 16 a, 16 b is filled by the elements 120.The best shape could be determined at least partly by studying the shapeof the gap between the native mitral valve leaflets 16 a, 16 b insystole after a clip structure 50 has been applied. The optimal shapefor the elements 120 for a particular patient anatomy may even be custommanufactured for that patient with rapid manufacturing techniques.Advantages of using rigid/static element(s) 120 include their ability towithstand repeated cycling forces perhaps better than a design thatrelies on one or more moving valve elements that may be more susceptibleto fatigue.

FIG. 12B more particularly shows a cut away view of the mitral valve 16from commissure to commissure. At the commissures, the anchors orconnectors 34, 36 are shown on each side—both above and below theleaflets 16 a, 16 b. Centrally, there is a clip structure 50 or otherattachment that anchors to the mitral valve leaflets 16 a, 16 b eitherindividually or together. A tensile or other connecting member 54extends up from the clip attachment component 50 and attaches to theframe member 32 which extends across the valve 16 from commissure tocommissure.

The frame structure 30 e can be constructed of a metal material such asstainless steel or Nitinol. Nitinol or other shape memory orsuper-elastic material may be preferred as this can be collapsed fordelivery via a catheter device inside the heart, and then expandedinside the heart for implantation.

The element(s) 120 may be constructed in a number of ways and havevarious shapes. They could be composed of a frame of metal such asNitinol that could be collapsed for catheter delivery. The metal framecould be covered by a plastic material or other artificial material likesilicone or Teflon or polyurethane. Animal or human pericardium andanimal or human heart valve material or any of the materials typicallyused for heart valve leaflet construction could be used to cover theframe structure 30 e. A synthetic material or bioengineered materialcould also be used to cover the frame structure 30 e.

The inside of the static occlusion elements 120 could be hollow. Or, abladder or sac could be inside to fill the hollow interior space of theelement(s) 120. The bladder could be filled with air or any gas or aliquid such as saline, sterile water, blood, antibiotic or antisepticfluid, polymer or curable fluid material. The use of a bladder to fillthe inside of the element 120 could eliminate the need or reduce theneed for a frame associated with the element 120.

The selective occlusion device 22 g has commissural and leafletattachments to anchor it in position. It would also be possible tocreate this apparatus without a leaflet attachment. For example, theattachment could be at the commissures only. It would not be necessaryto have a clip structure 50 and a member connected to the frame member32. In this case there would not need to be two occluding elements 120.A single occlusion element 120 could be used to fill any gap between thetwo leaflets 16 a, 16 b. The shape of course would be different—likelyan oval surface to extend between the commissures. The frame of such anelement could be similar to that previously shown and described inconnection with the first embodiment or another configuration.

FIG. 12C shows another illustrative embodiment or variation of aselective occlusion device 22 h mounted inside the heart to the nativemitral valve 16. There are two selective occluding elements 120 attachedto a frame structure 30 f. The frame structure 30 f is engaged with aclip structure 50 that is attaching the anterior and posterior leaflets16 a, 16 b together centrally, e.g., near the A2/P2 junction. The framestructure 30 f is stabilized by connectors 34, 36 at the commissures andannulus region 16 c of the valve 16.

The embodiment of FIG. 12C is similar to that shown in FIGS. 12A and12B. The difference here is that the support frame member 32 is notlocated above the elements 120 but below the elements 120. In otherembodiments the support frame member 32 is located above the selectiveocclusion device and been directed to the left atrium. In thisembodiment, the supporting frame member 32 is biased downward and towardthe left ventricle, generally below the mitral valve 16. Also, in thisembodiment, the frame member 32 can be directly connected to the clipstructure 50 that attaches the two leaflets 16 a, 16 b and the framestructure 30 f together. This may allow a procedure where the entiredevice is implanted at one time. The clip structure 50, with theselective occlusion device elements 120 coupled to frame structure 30 f,could be delivered by a catheter (not shown). The clip structure 50(with or without exposing the rest of the device) could be extrudedoutside the delivery catheter inside the heart 10. The clip structure 50may then be closed on the native mitral valve anterior and posteriorleaflets 16 a, 16 b. The remainder of the selective occlusion device 22h could be then released from the delivery catheter—placing the entiredevice in position. This may simplify the procedure to one step.

It is also important to note that in prior embodiments the framestructure has been above the clip structure 50, and in this embodiment,the frame structure 30 f is below. It is also possible to have both anupper and a lower support frame structure (such as by combining twoarc-shaped supports in one device). It would also be possible to joinupper and lower arc support or frame members, so the support or framestructure is a complete loop or circle. This may provide furtherstructural strength to the system.

FIG. 12D is a side elevational view schematically illustrating anotherillustrative embodiment of a selective occlusion device 22 i includingfirst and second rigid or static selective occlusion elements 120coupled with a frame structure 30 g. In this embodiment, the rigidselective occlusion elements 120 are directly coupled to the framestructure 30 g, which may be a frame member 32 coupled with the clipstructure 50. As in previous embodiments, the clip structure 50 maydirectly couple respective margins of the anterior and posterior mitralleaflets 16 a, 16 b, or may couple these leaflet margins togetheragainst an intermediate spacer (not shown). This may be used tocorrectly orient and locate the rigid selective occlusion elements 120on opposite sides of the clip structure 50 and within the side-by-sideopenings of the native mitral valve 16 created by the central clipstructure 50. Optionally, additional connectors 122, 124 shown in brokenlines may be used to help secure the rigid selective occlusion elements120 in place at the commissures of the mitral valve 16.

FIGS. 13A and 13B schematically illustrate, in cross section, thefunctioning of the rigid, selective occlusion elements 120 shown inFIGS. 12A through 12D. Specifically, when the heart cycle is in systolethe native mitral leaflets 16 a, 16 b will close against the rigidselective occlusion elements 120 to provide a fluid seal againstregurgitation of blood flow. As shown in FIG. 13B, during diastole, themitral valve leaflets 16 a, 16 b will spread apart and disengage fromthe rigid selective occlusion elements 120 to allow blood flow from theleft atrium 12 into the left ventricle 14 between the rigid selectiveocclusion elements 120 and the respective native leaflets 16 a, 16 b.The one or more elements 120 fill any gap between the anterior andposterior leaflets 16 a, 16 b. When mitral regurgitation occurs due tofailure of complete leaflet coaptation, the leaflets 16 a, 16 b arefrequently pulled apart from each other in the plane of the valve 16(here left-right). However, the situation may become more complexbecause the leaflets 16 a, 16 b tend to be pulled down into theventricle 14 as well as apart from each other as mitral regurgitationbecomes more severe over time. So, an up/down gap may also occur withone leaflet 16 a or 16 b sitting at a higher plane than the otherleaflet 16 a, 16 b.

The advantage to a convexly curved outer surface of the element(s) 120is that this surface can be shaped to adapt to a wide variety of defectsthat may occur between the anterior and posterior leaflets 16 a, 16 b.An outer, convexly curved surface of the element(s) 120 can accommodateleaflet gaps that are in the plane of the valve 16 (left right in thefigure) and perpendicular to the plane of the valve 16 (up and down inthe figure).

The selective occlusion device 22 g is symmetric on each side. Theelements 120 could also be constructed so that they are asymmetrical,i.e., not identical on opposite sides. For example, the posteriorleaflet 16 b may be more retracted into the left ventricle 14 than theanterior leaflet 16 a. It may be useful to have adjustments in theelement 120 on the side facing the posterior leaflet 16 b to fill thegap left by a retracted posterior leaflet 16 b. The element 120 may beconstructed to be more prominent on the side of the element 120 adjacentto the posterior leaflet 16 b than on the side adjacent or facing theanterior leaflet 16 a. One or more elements 120 may be adjustable inshape, such as by an adjustable level of inflation to a hollow interiorof the element 120 or other method, to accommodate any need to fill agap between the leaflets 16 a, 16 b that would otherwise causeregurgitation.

Custom made or custom size elements 120 could also be made depending onthe shape of the gap. A gap could be determined by echocardiography orCT and appropriately sized and shaped filling elements 120 could beselected based on measurements obtained with imaging. The valve defectthat needs repair may be more shaped as a cylinder and a cylinder orpyramid-cylinder shape may be better to stop blood regurgitation than alens or disc shape for the element(s) 120.

The margins of the element(s) 120 facing the oncoming flow of blood fromthe left atrium 12 has a tapering surface. This will allow the blood toflow smoothly into the left ventricle and avoid blood damage orhemolysis and to promote complete and unimpeded filling of the leftventricle 14. The edge of the element(s) 120 inside the left ventricle14 also demonstrates a taper similar to the inflow region of theelement(s) 120. When the heart begins to contract, blood will be ejectedback toward the element(s) 120 and the native leaflets 16 a, 16 b willbegin to move toward the element(s) 120 to produce a completeseal—preventing regurgitation of blood during systole.

An additional option is provided and illustrated in FIG. 13C. The rigidselective occlusion element(s) 120 may be formed in a fluid efficientmanner, such as a teardrop shape or other hemodynamic shape to preventundesirable blood flow patterns and damage or hemolysis as the bloodflows past the elements 120 in between the element 120 and therespective mitral leaflets 16 a, 16 b.

FIGS. 14A, 14B and 14C illustrate additional embodiments of selectiveocclusion devices 22 j, 22 k, 221 that utilize rigid or static selectiveocclusion elements 120. These elements 120 function as discussed abovein connection with FIGS. 12A through 12D and FIGS. 13A, 13B. In FIG. 14Athe rigid or static selective occlusion elements 120 are coupled to aframe structure 30 h that is secured along top margins of the elements120. At each end of the frame structure 30 h respective commissureconnectors 126, 128 are provided that include connecting elements whichoperate the same as the butterfly type elements previously described bysandwiching mitral tissue or other heart tissue therebetween. Additionalsecurement is provided by the clip structure 50 and a suitable tensileelement or other connector 54, such as also previously described.

FIG. 14B illustrates an embodiment of a selective occlusion device 22 kin the form of rigid or static elements 120 that are again generallydisc shaped and secured together by a frame member 32′, a tensileelement or connector 54 and a connected clip structure 50.

FIG. 14C illustrates an embodiment of a selective occlusion device 221in which the rigid selective occlusion elements 120 are secured togetherby fabric or other structure 129, and further secured through a tensilemember or other connector 54 to a clip structure 50 which secures theselective occlusion device 221 to the native mitral valve 16 through aclipping action as previously described.

FIGS. 15A through 15E illustrate another embodiment of a selectiveocclusion device 22 m including a flexible membrane 44 a and a framestructure 30 i. The flexible membrane 44 a is secured to frame structure30 i that is also preferably flexible for reasons such as previouslydescribed. This embodiment is similar to previous embodiments utilizingflexible membranes 44 a in conjunction with a mitral valve clipstructure 50, but includes a central reinforced area such as a fabricarea 130 allowing the native leaflet margin tissue to be a clippedagainst the reinforced fabric area 130 directly. The clip structure 50is shown in broken lines in FIG. 15E. In this alternative, the nativemitral tissue is not directly contacting abutting native mitral tissuebut instead contacts and is secured against the reinforced centralfabric area 130 of the flexible membrane 44 a. This fabric or otherreinforcing material 130 may, for example, be useful in situations wherethe remainder of the flexible membrane is formed from more delicatematerial such as biologic material. Annulus connectors 132, 134 areprovided and rest against an upper portion of the annulus 16 c asgenerally shown in other figures, such that the clip structure 50 (notshown in this embodiment) secures the selective occlusion device 22 m tothe reinforced, central area 130 from below, and the annulus connectors132, 134 secure the selective occlusion device 22 m from above bybearing against or otherwise coupling to the native annulus 16 c.

FIGS. 16A through 16D illustrate another illustrative embodiment of atranscatheter delivered selective occlusion device 22 n combined with aclip structure 50. Again, the clip structure 50 is used to affix a lowercentral margin portion of one leaflet 16 a to a lower central marginportion of the opposing leaflet 16 b, generally as previously described.Again, this clipping action may be for purposes of clipping the anteriorleaflet 16 a directly in contact with the posterior leaflet 16 b at thecentral location, or clipping the anterior and posterior leaflets 16 a,16 b against an intermediate spacer. In this embodiment, the selectiveocclusion device is coupled with the clip structure 50 delivered throughone or more catheters 52. As shown in FIGS. 16A and 16B, the catheterassembly 52 is delivered transeptally into the left atrium 12 anddownwardly through the native mitral valve 16 although other approachesmay be used instead in the various embodiments. The clip structure 50 isextruded from the catheter assembly distal end and, in the opencondition shown in FIG. 16A captures the leaflet margin portions asshown in FIG. 16B and is actuated to move one or both clip elements 50a, 50 b together into the position shown in FIG. 16C to secure thecentral leaflet margin portions together. The remaining portion of theselective occlusion device 22 n is then extruded from the distal end ofthe catheter assembly 52 as shown in FIG. 16C. As shown in FIG. 16D theselective occlusion device 22 n, which may be, as illustrative examples,of the type shown in FIG. 16D or any of the types otherwise shown anddescribed herein, or even other configurations contemplated hereby,self-expands into the mitral valve location. Operation of the selectiveocclusion device 22 n may be generally as described herein, andsecurement of the device 22 n occurs generally between the clipstructure 50 and respective annulus connectors 132, 134. Specifically,as previously discussed, the annulus connectors 132, 134 provide adownward force for securing the device 22 n generally at the annulus 16c, while the clip structure 50 provides an upward force to generallysecure the selective occlusion device 22 n therebetween in place in thenative mitral valve 16.

FIGS. 17A through 17C illustrate an embodiment of an apparatus fortranscatheter delivery and implantation. In this embodiment, the clipstructure 50 is delivered below the mitral valve 50 generally aspreviously described, and the selective occlusion device 22 n isdelivered to a location above the native mitral valve 16. The selectiveocclusion device 22 n is inserted into the mitral valve 16 and betweenthe native leaflets 16 a, 16 b, and also between the clip elements asshown in the method proceeding from FIG. 17A to 17B. Once in position asshown in FIG. 17B, at least one of the clip elements is moved toward theother clip element to clip or clamp the leaflet margins together, aspreviously described, and also to clamp a lower central portion of theselective occlusion device 22 n and, particularly, the flexible membrane44 a in this embodiment, such that the leaflet margins are securedtogether at the same time as the selective occlusion device 22 n issecured and implanted in place within the native mitral valve 16. Asshown in FIG. 17C, the selective occlusion device 22 n is fully extrudedfrom the catheter assembly, whereupon it self-expands into position inthe native mitral valve 16 and functions as otherwise generallydiscussed herein. More particularly, FIGS. 18A and 18B illustrate thediastole and systole portions, respectively, of the heart cycle with theapparatus secured in place as described in connection with FIGS. 17Athrough 17C. In FIG. 18A, during diastole, blood flow is allowed betweenthe native mitral leaflets 16 a, 16 b and the flexible membrane 44 a,while in systole the flexible membrane 44 a, in each section, fills withblood and thereby expands or inflates as the mitral leaflets 16 a, 16 bmove toward one another and against the flexible membrane 44 a to form afluid seal preventing regurgitation of blood flow from the leftventricle 14 into the left atrium 12 of the heart 10.

FIG. 19 is an anatomical view from above the native mitral valve 16 withthe selective occlusion device 22 n superimposed to show anotherrepresentation for the configuration in which the selective occlusiondevice 22 n is curved and flexes in accordance with the naturalcurvature of the mitral valve 16.

FIGS. 20, 21A, 21B and 21C illustrate another embodiment for a selectiveocclusion device 22 o and apparatus (combining the device 22 o with aclip structure 50), in which the selective occlusion device 22 o isconfigured generally as a two section device, but with the sections influid communication as best shown in FIG. 21A. A clip structure 50 issecured to the selective occlusion device 22 o at a position betweenrespective open ends 140, 142 of the sections. The clip structure 50 isused in the same manner as previously described. The flexible membrane44 b is supported by a flexible but strong frame structure 143, whichmay be formed in any manner contemplated herein, such as for allowingtranscatheter delivery and implantation. The open ends 140, 142 aredefined by hoop or ring portions 145, 147 of the frame structure 143.The hollow interior 144 of a flexible membrane 44 b receives blood flowin the systole portion of the heart cycle and fluid communicationbetween the two openings 140, 142 ensures better rinsing or washingduring the heart cycle to reduce the chances of blood clots.

FIGS. 22A through 22D illustrate another embodiment of an apparatus fortranscatheter delivery and implantation of a clip structure 50 coupledwith a selective occlusion device 22 p. A difference with thisembodiment is that the clip structure 50 clips the native mitralleaflets 16 a, 16 b against a central or intermediate spacer 150,instead of directly into contact with each other. The procedure isgenerally shown in FIGS. 22A through 22C in which the clip structure 50is first extruded from the transeptally directed catheter assembly 52generally at a location below the mitral leaflets 16 a, 16 b. Theleaflets 16 a, 16 b are captured against the intermediate spacer 150, asshown in FIG. 22B. The leaflets 16 a, 16 b are secured firmly againstthe spacer 150 as shown in FIG. 22C by moving at least one of the clipelements 50 a, 50 b toward the other. In this embodiment, each clipelement 50 a, 50 b is moved toward the central or intermediate spacer150 to clamp leaflet tissue against the spacer 150. The selectiveocclusion device 22 p, in this illustrative embodiment, is alreadysecured to the clip structure 50 when it is extruded from the catheterassembly 52 as illustrated in FIG. 22C whereupon the selective occlusiondevice 22 p self-expands into the implanted condition shown in FIG. 22D.It will be appreciated that the selective occlusion device 22 p may beextruded and implanted as a separate component, as well as coupled tothe clip structure 50 in a suitable manner, instead of being extruded inan already assembled form from the catheter or catheters 52.

FIG. 22E illustrates another embodiment, similar to that shown in FIG.22D, but further illustrating respective annulus connectors 154, 156 aspart of the selective occlusion device 22 p in the form of frame membersthat bear against heart tissue generally at the annulus 16 c in the leftatrium 12 and, additionally or optionally, frame members or connectors158, 160 (shown in broken lines) coupled with the selective occlusiondevice 22 p and located in the left ventricle 14 abutting the annulus 16c from below. Use of both sets of annulus connectors 154, 156, 158, 160results in sandwiching the heart tissue therebetween for bettersecurement.

FIG. 22F illustrates another embodiment of a device 22 q, similar toFIG. 22E, but illustrating a single annular connector 164 generallyencircling the native mitral valve 16 formed as part of the selectiveocclusion device and anchoring the selective occlusion device 22 q inthe native mitral valve 16 securely, preventing rocking in any directionbut allowing flexibility. As with all embodiments, the frame members maybe formed of any desired material, such as flexible wire-like materialsformed from polymers and/or flexible metals including super-elastic orshape memory materials. This can help achieve overall goals of theembodiments of flexibility for collapsed delivery and improved operationduring implanted use, as well as resistance against failure due tofatigue in this application involving continuous cycling in the heart.

FIG. 22G illustrates another embodiment of a device 22 r. The selectiveocclusion device 22 r may be as described in connection with any otherembodiment, but for illustrative purposes, is shown with a hollowflexible membrane 44 b, while the frame structure has been modified asshown. The frame structure includes a generally annular frame member 170such as described and shown in connection with FIG. 22F, but includingraised portions 170 a, 170 b relative to other portions. The raisedportions 170 a, 170 b are configured to be located adjacent and abovethe commissures of the native mitral valve 16 and are connected with acentral frame member 32 extending generally across the native mitralvalve 16 and formed as part of the selective occlusion device 22 r suchas with another connecting frame member 172. Such frame members at theannulus, as with all embodiments, may be above the annulus, below theannulus, or frame members/connectors may be above and below the annulusto sandwich tissue therebetween.

FIGS. 23A and 23B schematically illustrate a selective occlusion device22 s coupled with a central clip 50 including a spacer 150 implanted ina mitral valve 16. FIG. 23A illustrates the device 22 s and the mitralvalve 16 when the heart cycle is in systole, while FIG. 23B illustratesthe mitral valve 16 and the selective occlusion device 22 s when theheart is in diastole. The frame structure includes respective hoops orrings 180, 182 as shown in solid lines in FIG. 23A and broken lines inFIG. 23B. These define the openings 140, 142. A benefit of this frameconfiguration is that the frame will not contact the commissures duringrepeated heart cycling. The device, like other embodiments allows bloodflow from the left atrium to the left ventricle in diastole but preventsblood flow during systole.

FIG. 24 is a cross-sectional view schematically illustrating the mitralvalve 16 and the implanted selective occlusion device 22 s, coupled witha central clip structure 50 such as at a coupling 183. The selectiveocclusion device 22 s is of a type with a hollow interior 144 having twofluid communicating sections 184, 186 and respective first and secondopenings 140, 142 and a closed end 188. Fluid communication betweensections 184, 186 allows for better rinsing and washing action andreduced chance of clotting.

FIGS. 25A and 25B are schematic views of a selective occlusion device 22t, 22 t′ including a flexible membrane 44 b, 44 b′ with FIGS. 25A and25B showing the selective occlusion devices 22 t, 22 t′ when the heartcycle is in systole. The difference between the two devices 22 t, 22 t′is that the flexible membrane 44 b′ is integrated into the spacer 150 ofthe clip structure 50, while the flexible membrane 44 b is not. Flexiblemembrane 44 b and/or another portion, such as a frame portion, of device22 t may be otherwise coupled to clip structure 50 such as in the mannershown in FIG. 24 or another suitable manner.

FIGS. 26A, 26B and 26C schematically illustrate another illustrativeembodiment of an apparatus including a central clip structure 50 (FIG.26B) and a selective occlusion device 22 u. The selective occlusiondevice 22 u, as with previous devices shown and described herein, is ahollow fluid communicating structure having a flexible membrane 44 b andallowing blood flow into the hollow interior 144 defined by the flexiblemembrane 44 b in systole, as shown in FIGS. 26B and 26C. In diastole,the flexible membrane 44 b collapses inwardly, as previously shown anddescribed, to allow blood flow past the selective occlusion device 22 uand between the native mitral leaflets 16 a, 16 b from the left atrium12 into the left ventricle 14. In this embodiment, the orientation ofopenings 140, 142 and shape of the device 22 u force blood flow, insystole, toward the commissure regions as shown by the arrows. Theseforces help retain the device 22 u in place, in addition to any othersecurement such as the clip structure 50. In this way, rocking of thedevice 22 u may be reduced and the device 22 u can be more stable duringimplantation and use. These inlets 140, 142 are angled acutely away fromthe central clip structure 50 as shown in FIG. 26B.

FIG. 26D illustrates another embodiment of a selective occlusion device22 v in which a suitable baffle structure 190 is provided within theselective occlusion device 22 v for directing blood flow outwardly asshown by the arrows toward the connecting locations between the device22 v and the mitral annulus 16 c. This helps to produce securement forceand stabilization of the device 22 v in the implanted condition. Asingle opening 192 is provided for in flow during systole and the device22 v includes a closed end 194 and a hollow interior 195, such that thedevice 22 v fills with blood during systole and collapses to expel theblood during diastole as previously shown and described. A framestructure 196 is provided to support a flexible membrane 44 b, generallyas previously described, except that the frame structure is shaped andconfigured differently so as to form the single opening 192 defined by ahoop or ring frame member 197. It will be appreciated that the shapesand configurations of these structures may be modified from those shownin these illustrative examples.

FIG. 26E is an embodiment of a device 22 w that may be configured asprevious embodiments have been described, in terms of the selectiveocclusion device 22 w, but which includes a generally annular orcircular frame 200 structure that is a flat element for securing theapparatus in place in the mitral valve 16. The frame structure 200 isshown to rest and/or be secured in the left atrium 12 abutting againstheart tissue generally proximate the mitral annulus 16 c. However, itwill be appreciated that such a structure could be secured in othermanners, and that an additional lower support may be provided tosandwich heart tissue therebetween.

FIGS. 27A through 27C illustrate another embodiment of a selectiveocclusion device 22 x which may be constructed in accordance withprevious described embodiments, but including at least one small vent202 opposite to the two openings 140, 142 of the flexible membrane 44 b.The vent 202 is not large enough to result in any significantregurgitation or leakage of blood in systole. To the extent that thevent 202 does not allow any significant regurgitation of blood, this endof the flexible membrane is closed while the opposite end includes atleast one and, in this embodiment two openings 140, 142. Otherwise, thisembodiment of the flexible membrane 44 b operates and functions forpurposes and in ways as previously shown and described. One or morevents 202 may, for example, provide a pressure relief to reduce theforces against the device 22 x during high pressure systole portions ofthe heart cycle.

FIGS. 28A through 28C illustrate another embodiment of an apparatuscomprised of a central clip structure 50 and the previously describedselective occlusion device 22 p. In this embodiment, the clip structure50 includes a central gripping structure 210 which may have tines orother knurled, roughened or frictional surfaces. This will assist withclamping and retaining mitral leaflet margin tissue between therespective clip elements 50 a, 50 b and the selective occlusion device22 p. The clip structure 50 is secured to the selective occlusion device22 p, such as via the central gripping element 210. FIGS. 28B and 28Cfurther illustrate that the selective occlusion device 22 p operates inthe same manner, for example, as described above with fluidcommunication between two generally adjacent openings 140, 142 forincreased washing and rinsing.

FIGS. 29A, 29B and 30 illustrate the apparatus shown in FIGS. 28Athrough 28C in operation after being implanted in the mitral valve 16.Specifically, blood enters the selective occlusion device 22 p throughthe open ends 140, 142 and fills the interior 144 defined by theflexible membrane 44 b, whereupon the flexible membrane 44 b expands orinflates to engage in contact with the native mitral leaflets 16 a, 16 bforming a fluid seal that prevents regurgitation of blood flow duringsystole (FIGS. 29A and 29B). This is shown in FIG. 29B with the anatomyof the mitral valve 16 further shown and the native leaflet tissuecontacting the outside surfaces of the flexible membrane 44 b duringsystole.

FIG. 31 illustrates another embodiment showing an expandable prostheticheart valve 220, which may be comprised of a generally cylindrical outeror peripheral frame structure 222 and coupled with interior prostheticleaflets 224 that open and close to control blood flow therethrough.This is different from the other versions of a selective occlusiondevice which have at least one movable valve element (e.g., the flexiblemembrane that operates in conjunction with a native mitral leaflet), inthat this prosthetic heart valve 220 does not operate in conjunctionwith the native leaflet to control blood flow. Instead, the prostheticleaflets 224 control blood flow through the prosthetic valve 220.Coupled to the frame structure 222 are clip structures 50 or elementsthat directly couple the expandable prosthetic heart valve 220 to heartvalve leaflets, such as the mitral valve leaflets 16 a, 16 b aspreviously shown and described. FIG. 32A is a side elevational viewpartially fragmented to show the internal stent structure 226 exposedunderneath an outer covering 230, which may be natural, synthetic,biologic, bioengineered, or any other suitable medical grade materialuseful for cardiac devices of this type.

FIGS. 32B through 32E illustrate the succession of steps used to implantthe prosthetic valve 220 of FIGS. 31 and 32A. In particular, thisapparatus may be implanted through a transcatheter procedure, or a moreinvasive procedures such as a surgical procedure or keyhole type orother less invasive procedure. The collapsed or folded apparatus 220 isinserted between the mitral valve leaflets 16 a, 16 b as shown in FIG.32B, the clip structures 50 are used to capture the lower margins of themitral leaflets 16 a, 16 b (FIG. 32C) and clamp them as shown in FIG.32D. The expandable prosthetic heart valve 220 is then expanded againstthe native mitral leaflets 16 a, 16 b as shown in FIG. 32E to secure theimplanted prosthetic heart valve 220 in place within the native mitralvalve 16. The prosthetic leaflets 224 then open and close, respectivelyduring diastole and systole to allow and prevent the flow of bloodthrough the prosthetic heart valve 220.

FIG. 33 illustrates another embodiment, similar to the previousembodiment shown in FIG. 32 , but adding an upper flange element 236that helps secure the prosthetic heart valve 220 by stabilizing theheart valve 220 within the left atrium 12. In this regard the flange 236is mounted above the native mitral valve 16. The flange 236 may abutagainst heart tissue in the lower portion of the left atrium 12. FIG.34A is a side elevational view of the prosthetic heart valve 220 shownin FIG. 33 . FIG. 34B is an illustration of the prosthetic heart valve220 shown secured in place within the native mitral valve 16.

FIGS. 35A and 35B show another embodiment of a selective occlusiondevice 22 y mounted in a native mitral valve 16, as viewed in crosssection. This embodiment includes a flexible membrane 44 c with an openend facing the left ventricle 14, as in other embodiments, and receivingblood flow from below when the heart cycle is in systole (FIG. 35A). Inthis portion of the heart cycle, the flexible membrane 44 c expandsagainst the native leaflets 16 a, 16 b to reduce regurgitation aspreviously discussed. In diastole, the flexible membrane collapses andexpels the blood therein (FIG. 35B). Blood then travels in the reversedirection, generally, through the mitral valve 16 by flowing between thenative leaflets 16 a, 16 b and outer surfaces of the collapsed membrane44 c. A difference between this embodiment and others is that multipleclip structures 50 are used to secure the selective occlusion device 22y directly to the leaflets 16 a, 16 b. The leaflets 16 a, 16 b are notclipped to each other. It will be appreciated that even further clipstructures 50 may be used in this embodiment as well as others. In thisembodiment, a clip structure 50 secures one side of the flexiblemembrane 44 c to the anterior leaflet 16 a and another clip structure 50secures the flexible membrane 44 c to the posterior leaflet 16 b.

While the present invention has been illustrated by the description ofone or more embodiments thereof, and while the embodiments have beendescribed in considerable detail, they are not intended to restrict orin any way limit the scope of the appended claims to such detail.Additional advantages and modifications will readily appear to thoseskilled in the art. The invention in its broader aspects is thereforenot limited to the specific details, representative product and methodand illustrative examples shown and described. Accordingly, departuresmay be made from such details without departing from the scope of thegeneral inventive concept. For example, any of the individual featuresor aspects described herein may be utilized alone or together in anycombination depending on the desired results and attendant advantages.

The invention claimed is:
 1. Apparatus for treating blood flowregurgitation through a native heart valve, the native heart valveexposed to a heart cycle alternating between a diastole and a systolephase, the native heart valve having a first leaflet and a secondleaflet, the first and second leaflets having respectively a firstleaflet free margin and a second leaflet free margin, the first andsecond leaflet margins defining therebetween a natural opening allowingblood flow when the leaflet free margins are spaced apart relative toeach other during the heart cycle, the apparatus comprising: a clipstructure including a first clip element and a second clip elementmovable towards each other from an open position to a closed positionfor engaging therebetween the first and second leaflet free margins andto affix together the first and second leaflet free margins in a mannerto produce a clipped opening of the native valve with a first flowcontrol portion of the native heart valve formed between the nativeleaflets, a first commissure of the native leaflets, and the clipstructure and a second flow control portion of the native heart valveformed between the native leaflets, a second commissure of the nativeleaflets, and the clip structure; a flow control device coupleable tothe clip structure and configured and sized to be at least partiallydisposed in the clipped opening between the leaflet free margins in atleast one of the first flow control portion and the second flow controlportion and to engage with at least one of the first or second leafletsto reduce blood flow regurgitation during one of the alternating phasesof the heart cycle.
 2. The apparatus of claim 1, wherein the flowcontrol device is coupled to the clip structure.
 3. The apparatus ofclaim 1, wherein the flow control device is configured to be disposablein both the first flow control portion and the second flow controlportion of the native heart valve.
 4. The apparatus of claim 1, whereinthe flow control device and the at least one of the first or secondnative leaflets can engage one another to reduce blood flowregurgitation through the clipped opening of the native heart valve whenthe heart cycle is in systole, and disengage from one another to allowblood flow therethrough when the heart cycle is in diastole.
 5. Theapparatus of claim 2, wherein the flow control device includes a framestructure, and the flow control device is coupleable to the clipstructure through a frame member of the frame structure.
 6. Theapparatus of claim 5, wherein the frame structure includes an annulusconnector configured to engage with heart tissue proximate the annulusof the native heart valve to assist with securing the flow controldevice to the native heart valve.
 7. The apparatus of claim 6, whereinthe annulus connector is non-tissue piercing and is disposed proximateto a commissure of the native heart valve.
 8. The apparatus of claim 5,wherein the flow control device includes a flexible membrane connectedto the frame structure.
 9. Apparatus for treating blood flowregurgitation through a native heart valve, the native heart valveexposed to a heart cycle alternating between a diastole and a systolephase, the native heart valve having a first leaflet and a secondleaflet, the first and second leaflets having respectively a firstleaflet free margin and a second leaflet free margin, the first andsecond leaflet margins defining therebetween a natural opening allowingblood flow when the leaflet free margins are spaced apart relative toeach other during the heart cycle, the apparatus comprising: a clipstructure configured to affix together the first and second leaflet freemargins in a manner to produce a clipped opening of the native valve; aflow control device coupleable to the clip structure and configured andsized to be at least partially disposed in the clipped opening betweenthe leaflet free margins and to engage with at least one of the first orsecond leaflets to reduce blood flow regurgitation during one of thealternating phases of the heart cycle, the flow control device includinga first portion and a second portion, each configured to engage thefirst and second leaflets to reduce blood flow through the native heartvalve when the heart cycle is in systole and disengage the first andsecond leaflets to allow blood flow through the native heart valve whenthe heart cycle is in diastole, wherein the first portion is located ona first side of the clip structure and the second portion is located ona second, opposite side of the clip structure.
 10. The apparatus ofclaim 9, wherein each of the first and second portions is formed of aflexible membrane and includes a closed end and an open end, wherein theopen end fills with blood when the heart cycle is in systole to expandthe flexible membrane structure into engagement with the first andsecond native leaflets and the open end empties blood when the heartcycle is in diastole to collapse the flexible membrane structure toallow blood flow between the flexible membrane structure and the firstand second native leaflets.
 11. The apparatus of claim 1, wherein theflow control device includes a flexible membrane structure including afirst membrane portion disposed generally adjacent the first leaflet anda second membrane portion disposed generally adjacent the secondleaflet, the first and second membrane portions configured to engagewith the at least one of the first or second leaflets to reduce bloodflow through the native heart valve when the heart cycle is in systoleand to disengage with the at least one of the first or second leafletsto allow blood flow through the native valve when the heart cycle is indiastole.
 12. The apparatus of claim 11, wherein the clip structure isconfigured to secure the first membrane portion to the first leafletwith the first clip element, and to secure the second membrane portionto the second leaflet with the second clip element.
 13. The apparatus ofclaim 11, wherein the flexible membrane structure includes an open endand a closed end, the open end receives blood to fill the flexiblemembrane structure when the heart cycle is in systole thereby urging theflexible membrane portions into engagement with the at least one of thefirst or second leaflets and the flexible membrane structure emptiesblood through the open end when the heart cycle is in diastole therebydisengaging the flexible membrane portions from the at least one of thefirst or second leaflets to allow blood flow through the native heartvalve.
 14. The apparatus of claim 13, wherein the flexible membranestructure includes a vent in the closed end through which blood can passto provide a pressure relief to reduce forces against the flow controldevice during systole.
 15. The apparatus of claim 2, wherein the flowcontrol device is coupled to the clip structure between the first clipelement and the second clip element.
 16. The apparatus of claim 1,wherein the clip structure is configured and sized to capture theleaflet free margins while simultaneously coupling the flow controldevice to the clip structure through the leaflet capturing action. 17.The apparatus of claim 1, wherein the flow control device includes aprosthetic valve with a generally cylindrical support with prostheticleaflets disposed therein and configured to allow blood flowtherethrough in a first direction when the heart cycle is in diastoleand inhibit blood flow therethrough in a second, opposite direction whenthe heart cycle is in systole, the prosthetic valve disposed in one ofthe first flow control portion and the second flow control portion ofthe native heart valve.
 18. The apparatus of claim 1, wherein the flowcontrol device includes one or more frame members configured to engagewith heart tissue proximate the annulus of the native heart valve toassist in securing the flow control device to the native valve.
 19. Theapparatus of claim 18, wherein the flow control device is couplable tothe clip structure.
 20. Apparatus for treating blood flow regurgitationthrough a native heart valve including first and second native leaflets,the apparatus comprising: a selective occlusion device configured to beimplanted in the native heart valve and selectively operating with atleast one of the first or second native leaflets to allow blood flowthrough the native heart valve when the heart cycle is in diastole andreduce blood flow regurgitation through the native heart valve when theheart cycle is in systole; a frame structure coupled to the selectiveocclusion device; an annulus connector coupled with the frame structure,the annulus connector configured to engage with heart tissue, whereinthe frame structure is configured to extend across the native heartvalve and the selective occlusion device is secured in place generallybetween the frame structure and the annulus connector; and a clipstructure coupled with the selective occlusion device, the clipstructure configured to be affixed to a margin of at least one of thefirst or second native leaflets to secure the selective occlusion deviceto the native heart valve, wherein the clip structure includes a cliphaving a pair of clip elements, with at least one of the clip elementsmovable between open and closed positions, and the clip elementsconfigured to capture native leaflet tissue therebetween in the closedposition.
 21. The apparatus of claim 20, wherein the annulus connectoris configured to provide a first force on heart tissue at the annulusand the clip structure is configured to provide a second, opposing forceat a lower margin of at least one of the first or second native leafletsto hold the selective occlusion device therebetween.
 22. The apparatusof claim 20, wherein the selective occlusion device includes aprosthetic heart valve including a movable valve element configured toselectively control blood flow through the native heart valve.
 23. Theapparatus of claim 22, wherein the movable valve element includes aflexible membrane configured to engage the first and second nativeleaflets of the native heart valve when the heart cycle is in systoleand disengage the first and second native leaflets when the heart cycleis in diastole.
 24. The apparatus of claim 20, wherein the selectiveocclusion device includes a rigid element configured to be implanted inthe native heart valve such that at least one of the first or secondnative leaflets engages the rigid element when the heart cycle is insystole to reduce blood flow through the native heart valve, and the atleast one of the first or second native leaflets disengages the rigidelement when the heart cycle is diastole to allow blood flow through thenative heart valve.
 25. The apparatus of claim 20, wherein the selectiveocclusion device includes a flexible membrane structure including firstand second portions each configured to engage the first and secondnative leaflets of the native heart valve to reduce blood flow throughthe native heart valve when the heart cycle is in systole and disengagethe first and second native leaflets to allow blood flow through thenative heart valve when the heart cycle is in diastole, wherein thefirst portion is located on a first side of the clip structure and thesecond portion is located on a second, opposite side of the clipstructure.
 26. The apparatus of claim 9, wherein the flow control deviceis configured to be disposable in a first flow control portion of theclipped opening of the native heart valve formed between the nativeleaflets, a first commissure of the native leaflets, and the clipstructure affixing the leaflet free margins together.
 27. The apparatusof claim 26, wherein the flow control device is further configured to bedisposable also in a second flow control portion of the clipped openingof the native heart valve formed between the native leaflets, a secondcommissure of the native leaflets, and the clip structure.